11
D-0116492-B (OM022)
– Otosure Operating Manual
3.3.5.
ELECTROMAGNETIC COMPATIBILITY (EMC)
Although the instrument fulfills the relevant EMC requirements, precautions
should be taken to avoid unnecessary exposure to electromagnetic fields, e.g.,
from mobile phones, etc. If the device is used adjacent to other equipment it
must be observed that no mutual disturbance appears. Please also refer to the
appendix regarding EMC.
3.3.6.
EXPLOSION HAZARDS
Risk of explosion.
Do not use in the presence of flammable anesthetics or other gases.
Do NOT use in the presence of flammable gaseous mixtures. Users should
consider the possibility of explosions or fire when using this device in close
proximity to flammable anesthetic gases.
Do NOT use the Otosure in a highly oxygen-enriched environment, such as a
hyperbaric chamber, oxygen tent, etc.
3.3.7.
MEASURING SECURITY
To guarantee that the Otosure works properly, the instrument should be checked and calibrated at least once
a year. The transducers supplied with the audiometer are specifically calibrated with it; if these transducers
are changed recalibration will be required.
The service and calibration must be performed by an authorized service technician. If these checks are not
performed, EU Medical Device Directive (MDD) and other regulations may be violated and warranties may be
void.
The use of non-calibrated devices can lead to incorrect test results and is not advisable.
3.3.8.
MISCELLANEOUS
Please note:
DO NOT connect the Otosure hardware to the computer before the software has been installed!
Storage in temperatures below 0
C /32
F and above 50
C /122
F may cause permanent damage to the
instrument and its accessories.
Do not place the instrument next to a heat source of any kind.
Great care should be exercised when handling transducers, as rough handling, for example dropping onto a
hard surface may break or damage the parts.
Within the European Union it is illegal to dispose of electrical and electronic waste as unsorted
municipal waste. Electrical and electronic waste may contain hazardous substances and
therefore have to be disposed of separately. Such products will be marked with the crossed-
out wheelie-bin image shown to the left. User cooperation is important in order to ensure a
high level of reuse and recycling of electrical and electronic waste. Failure to recycle such
waste products in an appropriate way may endanger the environment and consequently the
health of human beings.
Outside the European Union, local regulations should be followed when disposing of the product after its end
of life.
CAUTION
WARNING
Summary of Contents for Otosure
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